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EN ISO 11810:2015

Current
Current

The latest, up-to-date edition.

Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
Published date

12-23-2015

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Significance and use of the test
6 Apparatus
7 Reagents and materials
8 Preparation of specimens
9 Preparation of apparatus
10 Test methods
11 Classification
12 Test report
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying surgical drapes and other patient-protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition.All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard.The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant itemsNOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.

Committee
CEN/TC 123
DevelopmentNote
Supersedes EN ISO 11810-1 & EN ISO 11810-2. (01/2016) Supersedes UNE EN ISO 11810-1 & UNE EN ISO 11810-2. (03/2016)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

17/30358658 DC : 0 BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
BS EN 13795-1 : 2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
PREN 13795-1 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
UNI EN 13795-1 : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
I.S. EN 13795-1:2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
DIN EN 13795-1 E : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
17/30362728 DC : 0 BS EN 17169 - TATTOOING - SAFE AND HYGIENIC PRACTICE
DIN EN 13795-1:2009-10 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS

ISO 80000-4:2006 Quantities and units Part 4: Mechanics
ISO 2947:1973 Textiles — Integrated conversion table for replacing traditional yarn numbers by rounded values in the Tex System
ISO 11146-1:2005 Lasers and laser-related equipment Test methods for laser beam widths, divergence angles and beam propagation ratios Part 1: Stigmatic and simple astigmatic beams
ISO 6940:2004 Textile fabrics — Burning behaviour — Determination of ease of ignition of vertically oriented specimens
ISO 9773:1998 Plastics — Determination of burning behaviour of thin flexible vertical specimens in contact with a small-flame ignition source
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
EN 13795:2011+A1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
ISO 4880:1997 Burning behaviour of textiles and textile products Vocabulary
ISO 139:2005 Textiles Standard atmospheres for conditioning and testing
ISO 1144:2016 Textiles Universal system for designating linear density (Tex System)
ISO 11145:2016 Optics and photonics Lasers and laser-related equipment Vocabulary and symbols
ISO 6941:2003 Textile fabrics Burning behaviour Measurement of flame spread properties of vertically oriented specimens

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